Pitavastatin calcium
- Createtime: 2026-04-14
- Updatetime: 2026-04-15
Product Details
| useage |
Industrial use
|
| deliveryInfo |
|
| appearance |
White to off-white crystalline powder
|
| Storage |
2–8 °C, sealed, dry, away from light
|
| aliasen |
|
| supplyCapacity |
50000Metric Ton/Month
|
| Solubility |
Slightly soluble in water and methanol; soluble in DMSO
|
| harbor |
Qingdao,China
|
| minorder |
1KG
|
| Structure |
Quinoline-based statin with fluorophenyl and cyclopropyl groups
|
| Melting Point |
182–185 °C
|
- Assay (HPLC): 98.0–102.0%
- Loss on Drying: ≤0.5%
- Melting Point: 182–185 °C (dec.)
- Single Impurity: ≤0.2%
- Total Impurities: ≤1.0%
- Residue on Ignition: 4.5–5.5% (Ca content)
- Heavy Metals (Pb): ≤10 ppm
- Optical Rotation: +19° to +24°


Applications
Pitavastatin Calcium is a high-efficiency HMG-CoA reductase inhibitor and a leading lipid-lowering API in cardiovascular therapeutics. As a third-generation statin, it potently blocks cholesterol biosynthesis in the liver, significantly reducing LDL-cholesterol and triglycerides while raising HDL-cholesterol. It is clinically indicated for primary hypercholesterolemia, mixed dyslipidemia, and prevention of atherosclerotic cardiovascular diseases (ASCVD) including coronary artery disease and stroke. Its unique fluorinated quinoline structure enhances metabolic stability and liver selectivity, lowering systemic adverse effects compared to older statins. It is also used in pharmaceutical formulation development, as a reference standard for analytical validation, and in lipid metabolism research. Widely prescribed alone or combined with ezetimibe, it improves lipid profiles in patients with diabetes or metabolic syndrome. As a key API, it supports large-scale generic production and meets global demand for affordable cardiovascular therapies.
Safety Information
Pitavastatin Calcium is classified as GHS07 Warning (H315, H319, H335) with mild acute toxicity. Inhalation of dust may irritate the respiratory tract, causing cough, sore throat, or mild dyspnea; long-term inhalation should be avoided. Skin contact may lead to redness, itching, or mild dermatitis, especially in sensitive individuals. Eye exposure causes stinging, conjunctival congestion, and tearing; irrigate eyes continuously with clean water for ≥15 minutes if contact occurs. Oral ingestion may cause nausea, diarrhea, or myalgia; rare risks include rhabdomyolysis and elevated liver enzymes, requiring periodic monitoring in clinical use. Operators must work in ventilated fume hoods, wearing dust masks, nitrile gloves, and safety goggles. Store separately from food, feed, and oxidants. Avoid environmental release; dispose of waste per hazardous waste regulations. Handle with caution during pregnancy and lactation, and use only under medical supervision.